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Chronic Kidney Disease Stage 3Phase 3DREAM-NDNCT04012957

Desidustat in the Treatment of Anemia in CKD

A Phase 3 study testing Desidustat Oral Tablet and Darbepoetin Alfa in people with Chronic Kidney Disease Stage 3 and Anemia, run by Zydus Lifesciences Limited at 32 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Desidustat Oral Tablet and Darbepoetin Alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
588 participants
Where
32 sitesIndia
Study dates
20 Jul 2019to 25 Aug 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
  • Ability to understand and give informed consent for participation.
  • Male or female patients diagnosed with CKD (stage III to V, not receiving dialysis) defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
  • Male or female, 18 to 80 years of age.
  • Body weight > 40 kg.
  • Subjects not on dialysis and not expected to start dialysis during the study period.
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  • Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy within 6 weeks prior to enrollment.
  • Estimated GFR ≥10 mL/min/1.73 m2.
  • Serum ferritin ≥100 ng/mL and/or Transferrin Saturation >20%.
  • No iron, folate or Vitamin B12 deficiency.
  • Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.

Who cannot join

  • Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
  • Intravenous iron within 14 days prior to enrollment.
  • Prior exposure of rhEPO analogues less than 04 weeks.
  • Red blood cell transfusion within 8 weeks prior to enrollment.
  • History of previous or concurrent cancer.
  • Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
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  • Active infection prior to enrollment.
  • History of renal transplant.
  • Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
  • Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; mal-absorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
  • History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
  • Presence or a history of bleeding disorders or clinical conditions (e.g. gastrointestinal [GI] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding.
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • History of severe allergic or hypersensitivity to investigational products and its excipients.
  • Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists or other medications within 28 days of the first dose of study drug that in the investigator's opinion, could compromise patient safety.
  • Pregnant and breastfeeding women.
  • Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
  • Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.
  • Presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) which, in the Investigator's opinion, could compromise the patient's safety.
  • History of significant alcoholism or drug abuse within the past 1 year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day).
  • History of difficulty with donating blood.
  • History or presence of any clinically significant ECG abnormalities during screening.
  • Participants who have participated in any drug research study other than the present trial within past 3 months.
  • Participants who have donated one unit (350 ml) of blood in the past 3 months or history of whole blood transfusion in last 120 days prior to enrollment.
  • History of chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease, Systemic Lupus Erythematosus [SLE]).
  • In case of Diabetes mellitus patients, glycosylated haemoglobin (HbA1c) >9 %.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

India32 sites

  • HCG Hospital

    Ahmedabad, Gujarat, 380006

  • Sangini Hospital

    Ahmedabad, Gujarat, 380015

  • GSC Medical College and Research Centre

    Ahmedabad, Gujarat, 380025

  • Thakershey Charitable trust Hospital

    Ahmedabad, Gujarat

  • Sapthagiri Institute of Medical Sciences

    Bangalore, Karnataka, 560090

  • Apollo Hospital

    Bhubaneswar, Odisha, 751005

  • Sardar Patel Medical College

    Bikaner, Rajasthan, 334003

  • Mahatma Gandhi Mission Medical College & Hospital

    Chhatrapati Sambhajinagar, Maharashtra, 431003

  • Shri Mahant Indiresh Hospital

    Dehradun, Uttarakhand, 248001

  • Fortis Hospital

    Delhi, New Delhi, 110070

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

  • Apollo Hospital

    Hyderabad, Telangana, 500058

  • Nizams Institute of Medical Sciences

    Hyderabad, Telangana, 500082

  • Nizams Institute of Medical Sciences

    Hyderabad, Telangana, 524001

  • Sawai Man Singh (SMS) Medical College and Hospital

    Jaipur, Rajasthan, 302004

  • Eternal Hospital

    Jaipur, Rajasthan, 302017

  • Rukmani Birla Hospital

    Jaipur, Rajasthan, 302018

  • Amrita Institute of Medical Science

    Kochi, Kerala, 682041

  • Medica Superspecialty Hospital

    Kolkata, West Bangal, 700099

  • Peerless Hospital

    Kolkata, West Bengal, 700094

  • Government Medical College

    Kozhikode, Kerala, 673008

  • Kasturba Medical College

    Mangalore, Karnataka, 575001

  • Nav Sanjeevani Hospital (Sankalp Speciality Healthcare Pvt. Ltd)

    Nashik, Maharashtra, 422002

  • Max Super Specialty Hospital

    New Delhi, National Capital Territory of Delhi, 110017

  • Noble Hospital

    Pune, Maharashtra, 411013

  • BAPS Pramukh Swami Hospital

    Surat, Gujarat, 395009

  • Bhaktivedanta Hospital and Research Institute

    Thane, Maharashtra, 401107

  • Asian Institute Of Medical Sciences (AIMS) Hospital

    Thane, Maharashtra, 421203

  • Sterling Hospital

    Vadodara, Gujarat, 390007

  • Dhiraj General Hospital

    Vadodara, Gujarat, 391760

  • Heritage Hospitals Limited

    Varanasi, Uttar Pradesh, 221311

  • Sunrise Hospital

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

About this study

Official title: A Phase 3, Multicenter, Multi-country, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Who Are Not on Dialysis

This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.

Being tested
Desidustat Oral Tablet, Darbepoetin Alfa
Keywords
DREAM-ND
Medical subject headings
Renal Insufficiency, Chronic, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desidustat Oral TabletDrug

    Desidustat tablet

  • Darbepoetin AlfaDrug

    Darbepoetin injection

Study groups in NCT04012957
Study groupRoleWhat they receive
Darbepoetin Alfa InjectionExperimentalRandomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.
Receives: Drug: Darbepoetin Alfa
Desidustat oral tabletActive comparatorRandomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
Receives: Drug: Desidustat Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin level

    Change in Hb levels from baseline

    Measured: 24 weeks

Secondary outcomes (2)

  1. Hemoglobin Response

    No. of subjects with Hb response

    Measured: 24 weeks

  2. Hemoglobin target range

    Time to achieve target range Hb level

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2019
  2. Study start20 Jul 2019
  3. Primary completion25 Aug 2021
  4. Study completion25 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
588 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04012957
Sponsor's protocol ID
DESI.18.001
Acronym
DREAM-ND
Status last verified
Jul 2020
First submitted
7 Jun 2019
Last updated
24 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

    PubMed 36005278

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desidustat Oral Tablet and Darbepoetin Alfa in people with Chronic Kidney Disease Stage 3 and Anemia, run by Zydus Lifesciences Limited at 32 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin level (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04012957, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.

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